# Curvafix, Inc.

- Location (FDA's records): Bellevue, WA
- FDA decisions: 3 (2019–2025): 3 510(k) clearances
- Product codes: HWC (3)
- 510(k) review time since 2016: median 70 days, against 111 for FDA's reviews in the same codes and years (2 of 3 faster)
- Predicates its devices cite: 6 (3 its own); citations of its devices by later devices: 4 (3 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Synthes (Usa): 2 (https://510kreport.com/company/synthes-usa)
- Smith & Nephew, Inc.: 1 (https://510kreport.com/company/smith-nephew)

## Firms that cite its devices most
- Illuminoss Medical, Inc.: 1 (https://510kreport.com/company/illuminoss-medical)

## Its most-cited devices
- K180050: CurvaFix Intramedullary Rodscrew System (2019), cited by 3
- K222505: CurvaFix IM System (2022), cited by 1

## Recent decisions
- K252019: CurvaFix Low Profile System (Aug 29, 2025)
- K222505: CurvaFix IM System (Oct 27, 2022)
- K180050: CurvaFix Intramedullary Rodscrew System (Mar 1, 2019)

Source page: https://510kreport.com/company/curvafix